An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)

September 13, 2018 updated by: Hoffmann-La Roche

AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER

This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital; Oncology Department
      • Birmingham, United Kingdom, B18 7QH
        • City Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary; Oncology Department
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Burton on Trent, United Kingdom, DE13 0RB
        • Queen's Hospital; Oncology Department
      • Colchester, United Kingdom, CO3 3NB
        • Essex County Hospital
      • Eastbourne, United Kingdom, BN21 2UD
        • Eastborne District General Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Wonford Hospital; Oncology Department
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Keighley, United Kingdom, BD20 6TD
        • Airedale General Hospital; Research Office Ward 12
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - London
      • Maidstone, United Kingdom, ME16 0FS
        • Maidstone Hospital; Kent Oncology Centre
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Middlesborough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Newport, United Kingdom, PO30 5TG
        • St Mary's Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • City Campus; Academic Unit of Oncology
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital; Cancer Clinical Trials Centre
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • City General Hospital
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Oncology
      • Torquay, United Kingdom, TQ27AA
        • Torbay Hospital; Oncology Department
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Wirral, United Kingdom, L63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital; Deansley Centre
      • York, United Kingdom, YO31 8HE
        • The York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer undergoing first-line treatment with chemotherapy and Avastin

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy
  • Initiating Avastin in combination with chemotherapy

Exclusion Criteria:

  • Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression
Time Frame: approximately 6 years
approximately 6 years
Safety: Incidence of adverse events
Time Frame: approximately 6 years
approximately 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival, defined as time from first administration of first-line therapy to documented death
Time Frame: approximately 6 years
approximately 6 years
Objective response rate, defined as percentage of patients with complete or partial response according to local assessments
Time Frame: approximately 6 years
approximately 6 years
Quality of life: EQ-5D/EORTC questionnaires
Time Frame: approximately 6 years
approximately 6 years
Dosage/schedule/duration of Avastin therapy
Time Frame: approximately 6 years
approximately 6 years
Composition of first-line chemotherapy regimens: drugs/dosage/duration
Time Frame: approximately 6 years
approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML28570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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